Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14534 |
| Brand Name: | Integra Duragen Graft Matrix |
| Model: | ID-1101(1), 1D-1105-(1), 1D-1301-(1), 1D-1305-(1), 1D-2201-(1), 1D-2205-1, 1D-3301(1) |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Integra Neurosciences Pty Ltd (NZ) 12 Florence Avenue Orewa Auckland 0931 |
| Contact Information: | 0800 400 660 |
| Manufacturer: | Integra LifeSciences Corporation |
| Brand Name: | Integra Duragen Plus |
| Model: | DP-1013-1, DP-1022-1, DP-1033-1, DP-1045-1, DP-5033 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Integra Neurosciences Pty Ltd (NZ) 12 Florence Avenue Orewa Auckland 0931 |
| Contact Information: | 0800 400 660 |
| Manufacturer: | Integra LifeSciences Corporation |
| Brand Name: | Integra Suturable Duragen |
| Model: | DURS2291 DURS3391, DURS4591 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Integra Neurosciences Pty Ltd (NZ) 12 Florence Avenue Orewa Auckland 0931 |
| Contact Information: | 0800 400 660 |
| Manufacturer: | Integra LifeSciences Corporation |
| Brand Name: | Integra Neuragen |
| Model: | PNG130, PNG230 , PNG520, PNG620, PNG630 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Integra Neurosciences Pty Ltd (NZ) 12 Florence Avenue Orewa Auckland 0931 |
| Contact Information: | 0800 400 660 |
| Manufacturer: | Integra LifeSciences Corporation |
| Brand Name: | Integra Neurawrap |
| Model: | NW320, NH340, NH520, NW740, NW1020, NW1040 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Integra Neurosciences Pty Ltd (NZ) 12 Florence Avenue Orewa Auckland 0931 |
| Contact Information: | 0800 400 660 |
| Manufacturer: | Integra LifeSciences Corporation |
| Issue: | Specific lots of some collagen products may have deviated from a production process. The affected lots passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. However, due to a process deviation, they may have been released with higher levels of endotoxins that permitted by release specifications. Higher endotoxin levels may result in fever in the immediate postoperative period. The manufacturer are not aware of any reports of patient injuries or other adverse events in connection with these product lots. The Health Hazard Evaluation (HHE) provided by the manufacturer details that during an internal quality assurance review of processes, specific lots manufactured during the periods December 2010 to May 2011, and then December 2012 to February 2013, may possibly be affected. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/4/2013 |
